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Agility Training in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Exercise therapy
Sponsored by
Somogy Megyei Kaposi Mór Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring sensorimotor training, exergaming, posture, quality of life

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Parkinson's disease
  • Hoenh Yahr scale of 2-3
  • Instability problem

Exclusion Criteria:

  • Severe heart problems
  • Severe demeanor
  • Alcoholism
  • Drug problems

Sites / Locations

  • Somogy Megyei Kaposi Mór Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Exercise therapy

Control

Healthy

Arm Description

Parkinson's disease group that receive 3 weeks of intensive exercise therapy in a rehabilitation center.

Parkinson's disease control group that will not receive exercise treatment.

A healthy group whose results will be compared with Parkinson's disease groups.

Outcomes

Primary Outcome Measures

EQ5D-5L
Questionnaire

Secondary Outcome Measures

Full Information

First Posted
May 31, 2017
Last Updated
April 29, 2020
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
Collaborators
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT03189680
Brief Title
Agility Training in Parkinson's Disease
Official Title
A High-Intensity Multi-Component Agility Intervention Improves Parkinson's Patients' Clinical and Motor Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 11, 2015 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
Collaborators
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the effects of an unusually highly intensity and individualized sensorimotor and visuomotor agility exercise program on non-demented PD patients' clinical symptoms, mobility, and postural stability.
Detailed Description
Design: Intervention study Setting: Outpatient rehabilitation center Participants: 55 Parkinson's disease (PD) patients completed the trial and 42 serves as comparison healthy controls Intervention: An initial screening established specific dysfunctions of PD patients with Hoehn-Yahr stage 2-3 who were then randomly assigned to standard care (n = 20) or standard care plus at-limit intensity, individualized agility program (15 sessions, 3 weeks, n = 35). Main outcome measures: Movement Disorder Society Unified Parkinson Disease Rating Scale, Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD symptoms In group time, repeated measurements of variance analysis were compared to the picture parkinson's disease based on MDS-UPDRS M-EDL, Beck depression score, PDQ-39, EQ5D VAS, Schwab & England scale. The TUG test and 12 static posturographic measurements are compared and compared to the healthy group as a standard. An at-limit and individualized sensorimotor and visuomotor agility exercise program vs. standard care, will improve non-demented, stage 2-3 PD patients' clinical symptoms, mobility, and postural stability by functionally meaningful margins.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
sensorimotor training, exergaming, posture, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The single-arm, 3-week-long intervention, administered daily, targeted postural instability and mobility using at-limit intensity sensorimotor and visuomotor agility training (n = 35, 17 males) conceptualized but seldom implemented previously. Each of the 15 training sessions lasted 60 minutes. Patients performed each exercise under increasingly difficult conditions and speed according to principles of periodization. All patients kept an exercise log detailing the positive and negative effects of the intervention on clinical and motor symptoms. The logs and attendance were checked daily. The no-intervention control, consisting of PD patients (n = 20, 12 males) received unsupervised standard care, consisting of the prescribed medications and daily, unsupervised 30 minutes of exercises at home.
Masking
Investigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise therapy
Arm Type
Experimental
Arm Description
Parkinson's disease group that receive 3 weeks of intensive exercise therapy in a rehabilitation center.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Parkinson's disease control group that will not receive exercise treatment.
Arm Title
Healthy
Arm Type
No Intervention
Arm Description
A healthy group whose results will be compared with Parkinson's disease groups.
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Other Intervention Name(s)
Control
Intervention Description
3-week-long intervention, administered daily, targeted postural instability and mobility using at-limit intensity sensorimotor and visuomotor agility training
Primary Outcome Measure Information:
Title
EQ5D-5L
Description
Questionnaire
Time Frame
0-5 scale (3 week-long, higher number is better)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parkinson's disease Hoenh Yahr scale of 2-3 Instability problem Exclusion Criteria: Severe heart problems Severe demeanor Alcoholism Drug problems
Facility Information:
Facility Name
Somogy Megyei Kaposi Mór Teaching Hospital
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30303934
Citation
Tollar J, Nagy F, Kovacs N, Hortobagyi T. Two-Year Agility Maintenance Training Slows the Progression of Parkinsonian Symptoms. Med Sci Sports Exerc. 2019 Feb;51(2):237-245. doi: 10.1249/MSS.0000000000001793.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/
Description
Related Info

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Agility Training in Parkinson's Disease

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